A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Investigation of Pharmacokinetics, Safety, and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Japanese and Non-Japanese Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05870670
• Other study ID #: NN9541-4921
• Secondary ID: U1111-1283-0710
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: October 16, 2023

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 16, 2023
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) between 23.0 kilogram per meter square (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). Overweight should be due to excess adipose tissue, as judged by the investigator.

• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

• For Japanese participants: Both parents of Japanese descent.

• For non-Japanese participants: Both parents of Caucasian descent.

Exclusion Criteria:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

• Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) at screening.

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• NNC0519-0130
Administered subcutaneously.
• Placebo
Administered subcutaneously.

Locations

Country	Name	City	State
Japan	SOUSEIKAI Sumida Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period	Measured in h*nmol/L.	From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Secondary	Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period	Measured in nmol/L.	From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)	Measured as number of events.	From time of dosing (day 1) until completion of the follow-up visit (day 105)